Label: EIGHT SAINTS CHASE THE SUN SPF-30- octocrylene, octisalate, zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 11, 2023

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  • Drug Facts

  • Active Ingredients

    Octocrylene 5.00%

    Octisalate 5.00%

    Zinc Oxide 4.00%

    Purpose

    Sunscreen

  • Uses:

    • Helps prevent sunburn • Higher SPF gives more sunburn protection • If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.

  • Warnings:

    • External use only.

    Do not use

    • on damaged or broken skin.

    When using this product

    • keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor

    • if irritation or rash develops.

    Keep out of reach of children.

    • If product is swallowed, get medical attention or contact poison control center immediately.

    If pregnant or breast-feeding,

    • ask a health professional before use.

  • Directions:

    • Apply well 15-minuets before sun exposure • Reapply atleast every two hours. Immediately after drying swimming, or sweating. Spending time in the sun increases your risk of cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: - Limit time in sun between 10am–2pm. - Wear long sleeve shirts, pants, hats and sunglasses. - For children under 6-months, consult a physician. SUN PROTECTION MEASURES:

  • Other Information:

    • Protect the product in this container from excessive heat and direct sun.

  • Other Ingredients:

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Extract, Caprylic/- Capric Triglyceride, Citric Acid, Cyclopentasiloxane, Cyclotetrasiloxane, Dacus Carota Sativa (Carrot) Extract, Citrullus Lanatus (Watermelon) Extract, Decyl Glucoside, Dimethicone, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Oil, Hyaluronic Acid, C13-14 Isoparaffin, Laureth-7, Lavandula Angustifolia (Lavender) Oil, Phenoxyethanol, Polyacrylamide, Punica Granatum (Pomegranate) Extract, Sclerocarya Birrea (Marula) Oil, Squalane, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate.

  • Package Labeling:

    LabelLabel2

  • INGREDIENTS AND APPEARANCE
    EIGHT SAINTS CHASE THE SUN SPF-30 
    octocrylene, octisalate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82247-384
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    CARROT (UNII: L56Z1JK48B)  
    WATERMELON (UNII: 231473QB6R)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
    SQUALANE (UNII: GW89575KF9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82247-384-001 in 1 BOX02/14/2022
    159 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02002/14/2022
    Labeler - BRICKELL BRANDS LLC (081141606)
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